REDWOOD CITY, Calif., Jan. 19, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals Inc.(Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an investigator-initiated study withUniversity Hospitals (UH) Cleveland Medical Centerthat will evaluate the postoperative use of DSUVIA in a prospective cohort of patients undergoing cardiac surgery with cardiopulmonary bypass following a specialized enhanced recovery protocol. Dr. Daniel Asher, cardiac anesthesiologist and Medical Director of the Mather Postanesthesia Care Unit at UH Cleveland Medical Center, will serve as the principal investigator.Key outcomes to be measured include time on mechanical ventilation following completion of the surgical procedure, both intensive care as well as hospital length of stay and total dose of opioids administered from surgery to discharge. These outcomes will be compared to historical controls utilizing current institutional standard of care techniques.
"We look forward to evaluating DSUVIA as part of our cardiac surgery enhanced recovery program which is aiming to better prepare our enrolled subjects for the stress of heart surgery by using contemporary preoperative adjuncts, educational tools, intraoperative monitoring techniques and, importantly, actively reducing the exposure of these patients to IV opioids and their side effects," states the study's co-investigator Dr. Edwin Avery, Vice Chair of Clinical Operations and Professor of Anesthesiology at UH Cleveland Medical Center, and Professor, Anesthesiology and Perioperative Medicine, Case Western Reserve University School of Medicine. "We believe the higher therapeutic index of sufentanil and the lower peak plasma concentrations delivered via the sublingual route compared to bolus IV administration will allow DSUVIA to help us achieve our goal," continues Dr. Avery.
"This investigator-initiated study at UH Cleveland presents another opportunity to assess the benefits of DSUVIA compared to IV opioids," said Dr.Pamela Palmer, Co-Founder and Chief Medical Officer atAcelRx Pharmaceuticals. "The physicians at UH Cleveland Medical Center have chosen DSUVIA for evaluation in their enhanced recovery cardiac bypass program to determine if it provides effective pain relief while minimizing side effects during their postoperative recovery prior to discharge. This cardiac surgery study together with ongoing investigator-initiated trials of DSUVIA for orthopedic and spine surgeries at other top academic institutions allows DSUVIA to be assessed across a broad range of surgical subspecialties as an alternative to IV opioids."
About DSUVIA(sufentanil sublingual tablet), 30 mcg DSUVIA, known as DZUVEOinEurope, approved by the FDA inNovember 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia.The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration.The European Commissionapproved DZUVEO for marketing inEuropeinJune 2018and the Company is currently in discussions with potential European marketing partners.
This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visitwww.DSUVIA.com.
AboutAcelRx Pharmaceuticals, Inc. AcelRx Pharmaceuticals, Inc.is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in theU.S., DSUVIA(sufentanil sublingual tablet, 30 mcg), known as DZUVEOinEurope, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso(sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in theU.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products inEurope.
For additional information about AcelRx, please visitwww.acelrx.com.
Forward-Looking Statements This pressrelease contains forward-looking statements, including, but not limited to, statements related to expected commencement of an investigator-initiated study and the scope of the study, expected findings from the investigator-initiated study and other studies, and the expected commencement of additional studies. These and any other forward-looking statements aremade pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. In addition, such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with theSecurities and Exchange Commission(SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company'sSECreports are available atwww.acelrx.comunder the "Investors" tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-announces-an-investigator-initiated-study-of-dsuvia-in-cardiac-surgery-enhanced-recovery-regimen-301210636.html
SOURCE AcelRx Pharmaceuticals, Inc.
- Home - MedStar Heart & Vascular Institute - April 16th, 2018 [April 16th, 2018]
- Guidelines for Standards in Cardiac Surgery - April 16th, 2018 [April 16th, 2018]
- Cardiac Surgery - University of Ottawa Heart Institute - June 16th, 2018 [June 16th, 2018]
- Cardiac Surgery | UNC Medical Center, Hospitals Chapel ... - June 18th, 2018 [June 18th, 2018]
- Heart Surgery | Seattle Childrens Hospital - June 18th, 2018 [June 18th, 2018]
- Pediatric Cardiac Surgery | CHKD | Norfolk, VA - June 18th, 2018 [June 18th, 2018]
- Cardiac Surgery | McLaren Port Huron - July 4th, 2018 [July 4th, 2018]
- CardioVascular Thoracic Institute (CVTI) | The most ... - July 23rd, 2018 [July 23rd, 2018]
- Top Cardiac Surgery COST in India| Benefit - IndianHealthGuru - July 27th, 2018 [July 27th, 2018]
- Cardiac Surgery - Atrial Septal Defect - August 6th, 2018 [August 6th, 2018]
- Cardiac Surgery | Stony Brook Medicine - August 6th, 2018 [August 6th, 2018]
- Cardiac Surgery in the Adult Fifth Edition: Lawrence H. Cohn ... - August 6th, 2018 [August 6th, 2018]
- Pioneers of Cardiac Surgery: 9780826515940: Medicine & Health ... - August 6th, 2018 [August 6th, 2018]
- Cardiovascular Surgery Department | Cleveland Clinic - August 6th, 2018 [August 6th, 2018]
- Cardiac Surgery - Massachusetts General Hospital, Boston, MA - September 19th, 2018 [September 19th, 2018]
- Cardiac Surgery | Surgery | UC Cincinnati College of ... - September 25th, 2018 [September 25th, 2018]
- Cardiothoracic surgery - Wikipedia - September 25th, 2018 [September 25th, 2018]
- Cardiac Surgery | NorthShore - September 25th, 2018 [September 25th, 2018]
- Open Heart Surgery - Cardiac Surgery - University of ... - September 25th, 2018 [September 25th, 2018]
- Heart Surgery | Cleveland Clinic - September 25th, 2018 [September 25th, 2018]
- Cardiac Surgery - Ventricular Assist Devices (VAD) - October 4th, 2018 [October 4th, 2018]
- VCSQI | Virginia Cardiac Services Quality Initiative ... - October 12th, 2018 [October 12th, 2018]
- Cardiac Surgery | Boston Medical Center - October 15th, 2018 [October 15th, 2018]
- Cardiac Surgery | WVU Heart and Vascular Institute - November 10th, 2018 [November 10th, 2018]
- Cardiac Surgery - Heart Valve, Bypass | GW Hospital - November 13th, 2018 [November 13th, 2018]
- Cardiac Surgery - Department of Surgery - University of ... - November 29th, 2018 [November 29th, 2018]
- Cardiac Surgery - Jersey Shore University Medical Center - December 7th, 2018 [December 7th, 2018]
- Blunt Cardiac Injury - The American Association for the ... - December 20th, 2018 [December 20th, 2018]
- Minimally invasive cardiac surgery - Wikipedia - December 20th, 2018 [December 20th, 2018]
- Heart Surgery | Private cardiac specialists in London ... - December 20th, 2018 [December 20th, 2018]
- Cardiac Surgery - Waterbury Hospital - December 20th, 2018 [December 20th, 2018]
- Cardiac surgery - Wikipedia - December 25th, 2018 [December 25th, 2018]
- Heart Surgery | Memorial Healthcare System - December 31st, 2018 [December 31st, 2018]
- A Step-By-Step Look at Open Heart Bypass Surgery - December 31st, 2018 [December 31st, 2018]
- Cardiac Surgery - Erlanger - December 31st, 2018 [December 31st, 2018]
- Inova Cardiac and Thoracic Surgery | Northern VA & DC - Inova - March 6th, 2019 [March 6th, 2019]
- Cardiac Surgery | Heart and Vascular Center | Dartmouth ... - March 13th, 2019 [March 13th, 2019]
- Cardiovascular Medicine and Cardiac Surgery - April 1st, 2019 [April 1st, 2019]
- Minimally invasive heart surgery - Mayo Clinic - April 3rd, 2019 [April 3rd, 2019]
- Home > Cardiac Surgery | Surgery | Yale School of Medicine - April 16th, 2019 [April 16th, 2019]
- Heart and Vascular Care Services - UR Medicine, University ... - April 18th, 2019 [April 18th, 2019]
- Welcome! | LHSC - April 20th, 2019 [April 20th, 2019]
- Cardiac Surgery | Department of Surgery | The University ... - April 20th, 2019 [April 20th, 2019]
- Coronary bypass surgery - Mayo Clinic - April 23rd, 2019 [April 23rd, 2019]
- Cardiovascular Surgery - Overview - Mayo Clinic - April 23rd, 2019 [April 23rd, 2019]
- Cardiac Surgery | McLaren Health Care - April 23rd, 2019 [April 23rd, 2019]
- Volunteer opens heart to his faith after healing cardiac ... - April 23rd, 2019 [April 23rd, 2019]
- Heart Surgery - UChicago Medicine - April 27th, 2019 [April 27th, 2019]
- Heart Surgery | UM St. Joseph Medical Center - May 13th, 2019 [May 13th, 2019]
- Cardiac Surgery - Billings Clinic - May 13th, 2019 [May 13th, 2019]
- Cardiology and Cardiac Surgery - Chicago Cardiologists and ... - May 23rd, 2019 [May 23rd, 2019]
- Cardiac Surgery | Michigan Medicine | University of Michigan - September 11th, 2019 [September 11th, 2019]
- Guidelines for Perioperative Care in Cardiac Surgery ... - September 11th, 2019 [September 11th, 2019]
- Cannula Market To Flourish And Reach USD 433 Million By 2025 - ZMR News Network - October 4th, 2019 [October 4th, 2019]
- Heart Health: Dr Panda says one should never give up on a patient - Republic World - October 4th, 2019 [October 4th, 2019]
- Minimally Invasive Surgery Market 2024 By Manufacturers, Investment Feasibility, Cost Structure And Swot Analysis - The Washington Observer - October 4th, 2019 [October 4th, 2019]
- Michael Schumacher health latest: What is stem cell therapy and how will it help Schumi? - Express.co.uk - October 4th, 2019 [October 4th, 2019]
- Cooperative insurance: Novel financing model aims to deliver healthcare to the middle-class segment - The Hindu BusinessLine - October 4th, 2019 [October 4th, 2019]
- Optimism Linked to Lower Risk of Cardiovascular Events and Death - Cath Lab Digest - October 4th, 2019 [October 4th, 2019]
- Global Cardiac Surgery Devices Market 2019 Innovative Trends and Insights Research upto 2024 - Markets Gazette - October 4th, 2019 [October 4th, 2019]
- Abiomed Receives FDA PMA Approval for Impella 5.5 With SmartAssist - Diagnostic and Interventional Cardiology - October 4th, 2019 [October 4th, 2019]
- Economics of Cochlear Implant Utilization : The Hearing Journal - LWW Journals - October 4th, 2019 [October 4th, 2019]
- How to Keep the Weight Off After Bariatric Surgery - Health Essentials from Cleveland Clinic - October 4th, 2019 [October 4th, 2019]
- Heart Lung Machine Market to Upsurge at 6.13% CAGR by 2023, Owing to Increasing Demand From the Healthcare Sector: Radiant Insights, Inc. - PRNewswire - October 4th, 2019 [October 4th, 2019]
- Annadale toddler born with rare condition is fighting for her life - SILive.com - October 4th, 2019 [October 4th, 2019]
- Ocala Health earns distinction, ranks among top within HCA open heart programs - Ocala News - October 4th, 2019 [October 4th, 2019]
- External Validation Of The Surgical Mortality Probability Model (S-MPM | TCRM - Dove Medical Press - October 4th, 2019 [October 4th, 2019]
- CytoSorb Removal of Ticagrelor Intraoperatively Results in Projected Cost Savings of Approximately $5,000 in Each Patient Undergoing Emergency Cardiac... - October 4th, 2019 [October 4th, 2019]
- Transcatheter Tricuspid Fix Bests Meds Alone in Early Results - Medscape - October 15th, 2019 [October 15th, 2019]
- Senior Lecturer/Associate Professor in Medical Statistics job with UNIVERSITY OF BRISTOL | 183393 - Times Higher Education (THE) - October 15th, 2019 [October 15th, 2019]
- Complicated surgery at NICVD saves life of nine-year-old boy - The News International - October 15th, 2019 [October 15th, 2019]
- Angion Announces Several Strategic Additions to its Management Team to Support the Future Development and Commercialization of ANG-3777 - Yahoo... - October 15th, 2019 [October 15th, 2019]
- 'Sky is the limit' for heart treatment without invasive surgery - Ottawa Citizen - October 15th, 2019 [October 15th, 2019]
- Executive Profile: Dr. David Anschel - Long Island Business News - October 15th, 2019 [October 15th, 2019]
- Heart surgeon and author reveals how he once set fire to patient - The Guardian - October 15th, 2019 [October 15th, 2019]
- Demolition paves way for heart, vascular center - Midland Daily News - October 15th, 2019 [October 15th, 2019]
- The basics of research | TNS - The News on Sunday - October 15th, 2019 [October 15th, 2019]
- Senior Lecturer/Associate Professor in Medical Statistics job with UNIVERSITY OF BRISTOL | 183345 - Times Higher Education (THE) - October 15th, 2019 [October 15th, 2019]
- Sparks, Accusations Fly Over Conduct of EXCEL Trial - Medscape - October 15th, 2019 [October 15th, 2019]
- More Heart Valve Patients May Choose Minimally Invasive Procedure - Newswise - October 15th, 2019 [October 15th, 2019]